PPT-Comparison of US/EU Biosimilar

Guidelines Kamali Chance MPH PhD RAC Senior Director Head Global Biosimilars Regulatory Strategy Definition of Biosimilarity Biosimilar Guidelines Issuance in the EU and US Regulation . Biosimilars. : Products, Recent Deals, IP Issues and Licensing. August 2, 2012. Madison C. Jellins. 1. Biologics Price Competition and Innovation Act. Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) signed into law March 2010. James C. Shehan. Hyman, Phelps & McNamara, P.C.. 700 Thirteenth Street, N.W., Suite 1200. Washington, D.C. 20005, U.S.A.. 202-737-9634 .  . jshehan@hpm.com. October 29, 2014. Agenda. BPCIA Overview. biosimilar. . ?. David Lim, Julie Hepworth, Lisa Nissen. c113.lim@qut.edu.au. CC-BY,NC Sarah Macmillan. Biotech . protein. Biotech . drug. Biopharmaceutical. Follow-on biologic . product < . 生. Schiestl M, Stangler T, Torella C, et al. . Nat Biotechnol.. 2011;29(4):310-2.. http://www.nature.com/nbt/journal/v29/n4/full/nbt.1839.html. Trial Design and Methods. Three major, marketed glycosylated biopharmaceuticals are reviewed, analyzing quality profiles of darbepoetin alfa, rituximab, and etanercept. View . from the Life Sciences . Industry. Moderator: Hans Sauer, Biotechnology Innovation Organization (BIO). Speakers. :. Peter . Cicala. , Celgene. Phil . Makrogiannis. , . Thermo. Fisher Scientific. Practical Legal/Regulatory Considerations Arising In The Course Of The Pathway’s Implementation. John M. Engel, Esq.. Managing Partner. Engel & Novitt, . l. lp. The Law Firm That Knows Its Science. interchangeability,extrapolation. and safety. Dr . Valderílio. . Feijó. . Azevedo. , MD, PhD. Universidade. Federal do Paraná. Edumed. Biotech. . Adjunct professor of rheumatology at the Federal University of Paraná, Brazil . . Professor of Medicine. Cleveland Clinic Lerner College of Medicine . RJ . Fasenmyer. Chair of Clinical Immunology. Cleveland Clinic. Cleveland, Ohio. Edward Li, . PharmD. , MPH, BCOP . Associate Professor. This program will include a discussion of off-label treatments and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.. & non-biological similar medicinal products . Cooperative European Medicines Development Course (CEMDC). 14. Appreciate the factors influencing the . adoption. . of follow-on drugs . in the everyday practice. . Guidelines. Kamali Chance, MPH, PhD, RAC. Senior Director . Head, Global . Biosimilars. Regulatory Strategy. Definition of . Biosimilarity. Biosimilar Guidelines Issuance in the EU and US. Regulation . Ms. Leah Goodman. Contents. Key Messages. An Overview - Biological Medicines and their Regulatory Framework. PhAMA Position and Recommendation on Biosimilars . An Overview - Biological Medicines and their Regulatory Framework. Key Issues and Challenges.  . Introduction. Differences Between Generics and Biosimilars. Clinical Development Program: . Biosimilars. Differences Between Development of New Generics and New Biosimilar Medications. 2016 . Clinical Investigator . Training Course. Sue Lim, M.D.. Medical Officer. OND Therapeutic Biologics and . Biosimilars. . Staff/CDER/FDA. November . 8. , 2016. Overview of Presentation. Biological products.